Guidance for Industry and FDA Staff. CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition

摘要

The purpose of this document is to establish internal Center for Devices and Radiological Health (CDRH) procedures for the identification and evaluation of consensus standards for recognition through publication of a notice in the Federal Register. This document may be amended in the future to include modified or additional procedures. The Food and Drug Administration Modernization Act (FDAMA) added section 514(c) to the Federal Food, Drug, and Cosmetic Act. This new provision states in part that FDA 'shall, by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act to which a standard is applicable.'